Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Myelomonocytic Leukemia
- de Novo Myelodysplastic Syndrome
- Myelodysplastic Syndrome
- Secondary Myelodysplastic Syndrome
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the effect of induction chemotherapy (IC) (intensive acute myeloid leukemia [AML]-like therapy), versus less intensive hypomethylating agents (HMA) as initial therapy, on failure-free survival. SECONDARY OBJECTIVES: I. Determine if IC (intensive AML-like therapy) ...
PRIMARY OBJECTIVES: I. To determine the effect of induction chemotherapy (IC) (intensive acute myeloid leukemia [AML]-like therapy), versus less intensive hypomethylating agents (HMA) as initial therapy, on failure-free survival. SECONDARY OBJECTIVES: I. Determine if IC (intensive AML-like therapy) in comparison to HMA as initial therapy, will affect transplantation frequency and quality of life. II. Conduct exploratory analysis of post-HCT outcomes (overall survival, and relapse). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC) for 7 days. Treatment repeats every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive induction-like chemotherapy per standard of care or per experimental protocol. This study does not require a specific chemotherapy regimen for Arm B. After completion of study treatment, patients are followed up for 18 months.
Tracking Information
- NCT #
- NCT01812252
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Bart L. Scott Fred Hutch/University of Washington Cancer Consortium